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Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00286364
First received: February 1, 2006
Last updated: April 20, 2007
Last verified: April 2007

February 1, 2006
April 20, 2007
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Complete list of historical versions of study NCT00286364 on ClinicalTrials.gov Archive Site
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Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial
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We want to investigate if early follicular phase downregulation and androgen priming, by use of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs of improvement compared to standard short antagonist protocol

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
Drug: Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH
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Lossl K, Andersen CY, Loft A, Freiesleben NL, Bangsbøll S, Andersen AN. Short-term androgen priming by use of aromatase inhibitor and hCG before controlled ovarian stimulation for IVF. A randomized controlled trial. Hum Reprod. 2008 Aug;23(8):1820-9. Epub 2008 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Indication and wish for IVF/ICSI treatment
  • Womens age 20-39 years (both inclusive)
  • Regular menstrual cycle within normal range
  • Body Mass Index: 18-30 kg/m2 (both inclusive)
  • Negative pregnancy test before treatment
  • A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy

Exclusion Criteria:

  • serious systemic disease
  • Presence of polycystic ovarian syndrome (PCOS)
  • Earlier poor response with less than 4 mature follicles
  • Earlier participation in the investigation
Female
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00286364
version 01.2005-05-20
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Rigshospitalet, Denmark
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Principal Investigator: Kristine Lossl, medical doctor The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet
Rigshospitalet, Denmark
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP